Method for supporting vaginal cuff

ABSTRACT

Described are methods and devices useful for supporting posterior vaginal tissue for various purposes such as treating or preventing vaginal prolapse or enterocele, especially in a patient not having a uterus, the devices including implants designed to contact the vaginal cuff and connect to sacral anatomy such as the sacrum or the uterosacral ligaments.

PRIORITY CLAIM

The present non-provisional patent application claims priority under 35USC § 119(e) from U.S. Provisional Patent Application having Ser. No.60/616,344, filed on Oct. 5, 2004, by Kovac, and titled METHOD FORSUPPORTING VAGINAL CUFF; and U.S. Provisional Patent Application havingSer. No. 60/666,457, filed on Mar. 28, 2005, by Kovac, and titled METHODFOR SUPPORTING VAGINAL CUFF, wherein the entirety of said provisionalpatent applications are incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to methods and devices for preventing or treatingvaginal prolapse, especially in women who have experienced ahysterectomy.

BACKGROUND

Female genital prolapse has long plagued women. With the increasing ageof the U.S. population these problems will likely assume additionalimportance.

Vaginal prolapse develops when intra-abdominal pressure affects theposition of the vagina, in severe cases causing the vagina to becomepositioned outside of the body. In a normal situation, the levator animuscles close the pelvic floor and support the vagina. This results inlittle force being applied to the fascia and ligaments that support thevagina. Increases in abdominal pressure, failure of the muscles to keepthe pelvic floor closed, and damage to ligaments and fascia, can allcontribute to the development of prolapse.

Conditions of posterior vaginal wall prolapse can involve descent of therectum into the vagina, often termed a rectocele, or the presence ofsmall intestine in a hernia sac between the rectum and vagina, called anenterocele. Broadly, there are four types based on suspected etiology.Congenital enteroceles are thought to occur because of failure of fusionor reopening of the fused peritoneal leaves down to the perineal body.Posthysterectomy vault prolapse can result from a lack of support fromdetachment of the uterosacral ligaments from the uterus at the time ofhysterectomy. Enterocele may occur because of failure to reapproximatethe superior aspects of the pubocervical fascia and the rectovaginalfascia at the time of surgery. Iatrogenic prolapse may occur after asurgical procedure that changes the vaginal axis, such as certainsurgical procedures for treatment of incontinence. With regard torectoceles, the most common type of rectocele results from disruption ofconnective tissue supports of the rectovaginal fascia from its normalattachments to the uterosacral ligaments. Posterior or posthysterectomyenteroceles may accompany rectoceles.

Several factors have been implicated as being involved in causingvaginal prolapse. It is thought that individual women have differinginherent strength of the relevant connective tissue. Further, loss ofconnective tissue strength might be associated with damage atchildbirth, deterioration with age, poor collagen repair mechanisms, andpoor nutrition. Loss of muscle strength might be associated withneuromuscular damage during childbirth, neural damage from chronicstraining, and metabolic diseases that affect muscle function. Otherfactors involved in prolapse include increased loads on the supportivesystem as seen in prolonged lifting or chronic coughing from chronicpulmonary disease, or some disturbance in the balance of the structuralsupport of the genital organs. Obesity, constipation, and a history ofhysterectomy have also been implicated as possible factors. In specific,the vaginal angle may be altered upon removal of the uterus, causingincreased pressure at a more acute angle, accelerating the prolapse.

Vaginal prolapse conditions can lead to discomfort, urinaryincontinence, and incomplete emptying of the bladder. Posterior vaginalprolapse may additionally cause defecatory problems such as tenesmus anddifficulty in stool evacuation.

Various techniques have been used to attempt to correct or ameliorateprolapse and prolapse symptoms, with varying degrees of success.Nonsurgical treatment of prolapse involves measures to improve thefactors associated with prolapse, including treating chronic cough,obesity, and constipation. Other nonsurgical treatments may includepelvic muscle exercises or supplementation with estrogen. Thesetherapies “may” alleviate some symptoms and temporarily provide somerelief to the patient, but the actual hernia will remain. Vaginalpessaries are the primary type of nonsurgical treatment, but potentialcomplications can occur such as vaginal wall ulceration.

Surgical treatments of posterior prolapse can involve vaginal andabdominal procedures to reapproximate the attenuated tissue usingsutures or a biological or synthetic implant to provide continuingsupport of the reapproximated tissue following the procedure. Implantsthat have been used to address pelvic organ prolapse are described,e.g., in U.S. patent Publication No. 2004/0039453 (Ser. No. 10/423,662),and U.S. patent application Ser. No. 10/834,943, entitled “Method andApparatus for Treating Pelvic Organ Prolapse,” filed Apr. 30, 2004,these patent applications being incorporated entirely herein byreference.

An example of a specific implant product designed for treatingconditions of vaginal vault prolapse include the APOGEE® product fromAmerican Medical Systems. Very generally, these devices are designed tobe implanted in a manner to support vaginal tissue. The APOGEE devicesand similar products can include various designs, such as “strips” of asingle material or pieces of the same or different materials connectedtogether (e.g., mesh, tape, optionally including synthetic or biologicaltissue portions) to form an implant that can be attached at one portionto vaginal tissue, with another portion attached at a position of theanatomy that supports the vaginal tissue.

SUMMARY

The invention relates to devices, methods, and kits, useful forsupporting vaginal tissue in a patient who does not have a uterus. Theinvention relates to an implant that is designed specifically to supportthe vaginal cuff remaining after removal of the uterus and cervix, e.g.,to support the pericervical ring created upon removal of the uterus andcervix. The support attaches to posterior vaginal tissue remaining afterremoval of the uterus and cervix, and attaches also to anatomy tosupport the vaginal tissue, at or around the sacrum such as touterosacral ligaments or to the sacrum itself (i.e., to a component ofthe sacral anatomy). The implant can be attached to a component of thesacral anatomy by any chemical or mechanical attachment such as by anadhesive, a suture, a bone screw or bone anchor, a staple, or any otherfastener for tissue or bone.

According to embodiments of the invention, a surgeon uses an implantabledevice (“implant”) such as a support member, a support strip, or animplant that includes a central support portion attached to twoextension portions, to attach to the pericervical ring or vaginal cuffremaining following removal of the uterus and cervix. The implant can beattached to uterosacral ligaments or the sacrum to support the implantand the vaginal vault. The implant may optionally be further supportedby attachment of extension portions of the implant to other anatomicalfeatures, e.g., a tissue path to an external incision, to therebyfurther support the vaginal vault.

An implant can include a support portion for attachment to the vaginalcuff. Specific examples of implants can include a support portiondesigned to be attached to the vaginal cuff, e.g., to fit around andcontact different portions of the vaginal cuff including the apex. Thesupport portion can also include one or more features or areas to attachto a component of the sacral anatomy such as the uterosacral ligamentsor the sacrum, to support the vagina and treat or prevent vaginal wallprolapse. The support portion can be designed and installed to preventpossible future enterocele formation.

Optionally the implant can include one or two extension portionsattached to the support portion and extending in opposite directionsfrom the support portion. Exemplary implants can include two extensionportions extending in opposite directions from a central supportportion. The extension potions can be sized and shaped to extend fromthe central support portion, to be attached to an anatomical positionthat provides support for the central support portion attached to thevaginal cuff. For example, extension portions can be led through tissuepaths from the interior pelvic area to external incisions, with theextension portions becoming ingrown in a manner to support the centralsupport portion of the implant attached to the vaginal cuff.

The implant can be installed in a patient who does not have a uterus,e.g., after removal of the uterus and cervix. The implant can beinstalled at the time of removal of the uterus as part of a hysterectomyprocedure. Alternately, the implant can be installed later, in asubsequent surgical procedure, in a patient who has had an earlierhysterectomy, such as during a subsequent procedure to treat or preventvaginal vault prolapse and enterocele formation.

An exemplary method according to the invention can involve, generally,introduction of an implant into the pelvic region (e.g., transvaginallyor abdominally) and attaching the implant to the vaginal cuff. Theimplant is also attached to a component of sacral anatomy such as theuterosacral ligaments or directly to the sacrum itself, to support thevaginal vault. In a patient who has sufficiently intact uterosacralligaments, a surgeon may opt to keep these ligaments in place and attachthe implant to the uterosacral ligaments. In instances where theuterosacral ligaments are damaged or not completely intact, not ofsufficient length, or for another reason, the surgeon may opt to attachthe implant directly to the sacrum.

Extension portions of an implant can be attached anatomically to supportthe support portion of an implant attached to the vaginal cuff. Anexemplary mode of placement of extension portions of an implant can bebilateral passage of the extension portions through tissue paths leadingto an external incision, such as an external incision at a perirectalregion as discussed in copending U.S. patent application Ser. No.10/834,943, filed Apr. 30, 2004, entitled “Method and Apparatus forTreating Pelvic Organ Prolapse. This exemplary method can include stepsof establishing a first pathway between the external perirectal regionof the patient and the region of the ischial spine space in tissuegenerally on one side of the vaginal cuff, and establishing a secondcorresponding pathway in tissue on the contralateral side of the vaginalcuff. Exemplary implants as described, including a central supportportion and two extension portions, can be attached to the vaginal cuffin such a way as to allow repositioning of the vaginal cuff to ananatomically appropriate location. The extension portions of the implantcan then be introduced through the respective bilateral tissue pathways.The extension portions can be adjusted so that the implant and centralsupport portion are located in a therapeutic relationship to the vaginalcuff being supported.

An aspect of the invention relates to a method of supporting vaginaltissue. The method includes: providing a surgical implant comprising asupport portion, attaching the support portion to vaginal or cervicaltissue remaining upon removal of a uterus, cervix, or both, andattaching the support portion to a component of sacral anatomy.

Another aspect of the invention relates to a transvaginal method ofsupporting vaginal tissue. The method includes: providing a surgicalimplant, transvaginally attaching the surgical implant to vaginal orcervical tissue remaining after removal of a uterus, cervix, or both,and transvaginally attaching the support portion to a component ofsacral anatomy.

Another aspect of the invention relates to a surgical implant. Theimplant includes a central support portion and two extension portionsextending longitudinally from the central support portion. The centralsupport portion includes: an anterior lobe extending laterally from theextension portions and a posterior lobe extending laterally from theextension portions in a direction opposite of the anterior component.The posterior lobe includes two lobe extensions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example of a surgical implant as described herein.

FIGS. 2 and 2A illustrates an example of a surgical implant as describedherein, with FIG. 2A showing side view and FIG. 2 showing a top view.

FIG. 3 illustrates an example of a surgical implant as described herein.

FIG. 4 illustrates an example of a surgical implant as described herein.

FIG. 5 illustrates relevant pelvic anatomy related to methods asdescribed herein, prior to installation of an implant.

FIG. 5 illustrates relevant pelvic anatomy related to methods asdescribed herein.

FIG. 6 illustrates relevant pelvic anatomy related to methods asdescribed herein, including an implant.

FIG. 7 illustrates relevant pelvic anatomy related to methods asdescribed herein, including an implant.

FIG. 8 illustrates relevant pelvic anatomy related to methods asdescribed herein, including an implant.

FIG. 9 illustrates relevant pelvic anatomy related to methods asdescribed herein, including an implant.

All figures are exemplary, schematic, and are not necessarily to scale.

DETAILED DESCRIPTION

The invention relates to devices, methods, and kits, useful forsupporting vaginal tissue in a patient who does not have a uterus. Theinvention relates to an implant that is designed specifically to supportvaginal cuff and optionally cervical tissue remaining after removal ofthe uterus, the cervix, or both, e.g., to support the pericervical ringcreated upon removal of the uterus, cervix, or both. The supportattaches to vaginal or cervical tissue remaining after removal of theuterus and optionally cervix, and attaches also to anatomy to supportthe vaginal tissue, at or around the sacrum such as uterosacralligaments or the sacrum itself (i.e., a component of the sacralanatomy). The implant can be attached to a component of the sacralanatomy by any chemical or mechanical attachment such as by an adhesive,a suture, a bone screw or bone anchor, a staple, or any other fastenerfor tissue or bone.

A useful implant can be any implant that can be fit to the vaginal cufffollowing removal of the uterus, cervix, or both, optionally withsuturing of vaginal tissue to close the vaginal vault. (The term“vaginal cuff” is used herein to refer to the vaginal cuff, and also thevaginal cuff as that tissue may also include the cervix or a portion ofthe cervix if cervical tissue remains following a hysterectomy.”) Theimplant can also attach to a component of the sacral anatomy such as auterosacral ligament or the sacrum to support the vaginal cuff in adesired position.

Exemplary implants can consist of or include a support portion sized andshaped to attach to a vaginal cuff location where the uterus andoptionally the cervix has been removed, in a patient who has had ahysterectomy. The vaginal cuff may be sutured to close the vaginal vaultand the implant may fit over the vaginal cuff. The support portion canbe used to close or cover the vaginal cuff by contacting differentportions of vaginal cuff tissue. For example, the support portion can besized and shaped to contact a posterior portion of the vaginal cuff(e.g., rectovaginal fascia) and also an anterior portion of the vaginalcuff (e.g., pubovaginal fascia), to cover the vaginal cuff from theposterior to the anterior locations of the vaginal cuff, including theapex.

Exemplary implants can include a central support portion and twoextension portions, the central support portion being useful to attachto the vaginal cuff and a component of the sacral anatomy. The centralsupport portion can be sized and shaped to attach to the vaginal cuff atmultiple locations such as at a posterior location (e.g., rectovaginalfascia) and an anterior location (e.g., pubovaginal fascia). The centralsupport portion can also be adapted (e.g., sized and shaped) to attachto a component of sacral anatomy such as the uterosacral ligaments orsacrum. As an example, a posterior lobe of a central support portion caninclude one or more lobe extensions that are of a size and shape to beattached to the sacrum or to one or more uterosacral ligaments.

Extension portions connected to and extending from a central supportportion can be useful to attach to other anatomical features to providefurther support for the central support portion and the attached vaginalcuff. The two extension portions can extend from the central supportportion as elongate “arms” or extensions that are attached to otheranatomy, such as by extending through a tissue path to an externalincision. See, e.g., U.S. patent publication number 2005/0080317, havingU.S. Ser. No. 10/684,861, filed Oct. 14, 2003, the entirety of which isincorporated herein by reference.

The total shape of exemplary implants, e.g., including a central supportportion and extension portions, can accommodate surgical placement ofthe implant to attach to anatomy as described herein to support thevaginal cuff. For an implant that includes a central support portion andtwo extension portions, the extension portions can be connected atopposing sides of the central support portion and can extendlongitudinally in opposite directions away from the central supportportion. For these exemplary implants the central support portion islocated between the two extension portions to bridge the two extensionportions together, and the central support portion is wider than the twoextension portions in that the central support portion extends laterallybeyond the width of the extension portions. These portions or “lobes” ofthe central support portion that extend laterally beyond the width ofthe extension portions can be referred to as anterior and posteriorlobes of the central support portion. Thus, a central support portioncan be referred to as comprising an anterior lobe extending laterallyfrom the extension portions and a posterior lobe extending laterallyfrom the extension portions in a direction opposite of the anteriorcomponent.

A support portion can be shaped to fit vaginal and optionally cervicaltissue remaining after a hysterectomy (i.e., sometimes referred to asthe “vaginal cuff,” for purposes of this description) and may begenerally rectangular, round, oval, oblong, etc., with the anterior lobeand the posterior lobe being of the same or different size or shaperelative to each other. According to particular embodiments, a posteriorlobe of a support portion can include two lobe extensions that are eachadapted to attach to the sacrum or to a uterosacral ligament. Inparticular embodiments, an implant can be prepared and supplied withlobe extensions that are sufficiently long to reach the sacrum—shouldthat implant be used in a procedure that includes attaching the lobes tothe uterosacral ligaments, the lobes can be trimmed in length toaccommodate the reduced distance from the installed support portion touterosacral ligaments.

Lobe extensions can be rectangular or square extensions off of a mainlobe body, optionally including a curvature if desired, and extending adistance from the main lobe body sufficient to extend from the sacrum tothe vaginal vault or cuff following hysterectomy with removal of thecervix, such as a distance in the range from 1 to 5 centimeters. Thelobe extensions can be trimmed for accommodating distances at the lowend of this range. The width of a lobe extension can be sufficient toallow attachment to a uterosacral ligament or the sacrum, such as awidth in the range from about 0.5 centimeters to 1.5 centimeters.

Materials useful for an implant (e.g., support portion, extensionportion, central support portion, etc.) can be any of a variety ofsynthetic or biologic materials. Exemplary extension and supportportions can be prepared from any combination of synthetic and biologicor natural materials. For example, an extension portion or a supportportion may be made of a synthetic mesh; e.g., an entire implantconsisting of a support portion alone or a central support portion andextension portions may be made entirely of a one-piece mesh. In otherembodiments exemplary extension portions can be of synthetic mesh and acentral support portion can be of a synthetic or biologic tissuematerial. Components of a multi-piece or multi-material implant may bepre-attached or pre-assembled, e.g., attached during manufacture, so asurgeon is not required to spend significant time cutting, connecting,or otherwise assembling the pieces of an implant prior to a surgicalinstallation procedure.

A synthetic implant material can be any synthetic material that can beuseful in an implantable surgical device, such as a biocompatiblepolymeric material or a biocompatible non-polymeric synthetic material.Examples of useful polymeric materials that may be useful in a polymericmesh include thermoplastic polymeric materials such as polyolefins(e.g., polypropylenes), polyurethanes, acetel materials, Teflon®materials, and the like; thermoset materials such as silicones; andmaterials that are otherwise curable, e.g., that can be cured byultraviolet radiation or chemical reactions, including curable materialssuch as curable urethanes, epoxies, acrylates, cyanoacrylates, and thelike. Any of these materials may be homopolymers, copolymers, or a blendor other combination of homopolymers, copolymers, or both. Othersuitable synthetic materials include metals (e.g. silver filigree,tantalum gauze mesh, and stainless steel mesh).

A synthetic implant material may be in any form, such as a continuous,solid, or semi-continuous (e.g., perforated) film; or in the form ofcombined fibers or strands, e.g., a braided, knit, tied, mesh, woven,non-woven, or fabric-type of material; or combinations of these. Certainembodiments of implants include a synthetic implant portion in the formof a polymeric mesh material. The mesh material includes one or morewoven, knitted or inter-linked polymeric filaments or fibers that formmultiple fiber junctions throughout the mesh. The fiber junctions may beformed via weaving, knitting, braiding, joining, ultrasonic welding orother junction forming techniques, including combinations thereof,leaving openings or pores (“interstices”) between elements of thefibers. The size of the interstices mesh may be sufficient to allowtissue in-growth and fixation within surrounding tissue.

Many different types of synthetic film and mesh materials are known andmay be suitable for use as a portion or piece of an implant such as anextension portion or a central support portion. These materials may beprepared from biocompatible materials that may be bioabsorbable ornon-bioabsorbable, e.g., in the form of mesh materials. Suitablematerials include cotton, linen, silk, polyamides (polyhexamethyleneadipamide (nylon 66), polyhexamethylene sebacamide (nylon 610),polycapramide (nylon 6), polydodecanamide (nylon 12), andpolyhexamethylene isophthalamide (nylon 61), and copolymers and blendsthereof), polyesters (e.g., polyethylene terephthalate, polybutylterephthalate, copolymers and blends thereof), fluoropolymers (e.g.,polytetrafluoroethylene and polyvinylidene fluoride), polyolefins (e.g.,polypropylene, including isotactic and syndiotactic polypropylene andblends thereof, as well as blends composed predominantly of isotactic orsyndiotactic polypropylene blended with heterotactic polypropylene, andpolyethylene), silicone, polygalactin, Silastic, polycaprolactone,polyglycolic acid, poly-L-lactic acid, poly-D-L-lactic acid andpolyphosphate esters.

Commercial examples of polymeric materials for use in an implant includeMARLEX (polypropylene) available from Bard of Covington, RI; PROLENE(polypropylene) and PROLENE Soft Polypropylene Mesh or Gynemesh(nonabsorbable synthetic surgical mesh), both available from Ethicon, ofNew Jersey; MERSILENE (polyethylene terephthalate) hernia mesh alsoavailable from Ethicon; GORE-TEX (expanded polytetrafluoroethylene)available from W. L. Gore and Associates, Phoenix, Ariz.; INTEPRO™polypropylene materials, and the polypropylene material used in thecommercially available SPARC® sling system, each available from AmericanMedical Systems, Inc. of Minnetonka, Minn. Commercial examples ofabsorbable materials include DEXON (polyglycolic acid) available fromDavis and Geck of Danbury, Conn., and VICRYL available from Ethicon.

Suitable non-synthetic (biologic) implant materials include allografts,homografts, heterografts, autologous tissues, cadaveric fascia,autodermal grafts, dermal collagen grafts, autofascial heterografts,whole skin grafts, porcine dermal collagen, lyophilized aortichomografts, preserved dural homografts, bovine pericardium, and fascialata.

According to certain embodiments of implants, various additionalcomponents and features can be incorporated for added utility orconvenience, such as components and features that facilitateinstallation of a device during a surgical procedure. For instance, atensioning member (e.g., suture) may be attached to an implant along aportion or entire length of an extension member for use in addingtension or in positioning an implant or a portion (e.g., extension) ofan implant. Alternately or in addition, an exemplary implant may includea removable sheath such as a plastic, transparent elongate tube, etc.,that can cover a portion or entire length of an extension portion of animplant to facilitate installation by allowing a surgeon to applytension or pressure on the sheath to indirectly apply pressure ortension to the extension portion. Additionally or alternately, extensionportions of an implant may include a connector or “dilator” tip at anend of an extension member distal from a central support member, theconnector being able to cooperate with an insertion tool (e.g., needle,tunneler, etc.) during a surgical procedure to either push or pull theconnector using the end of the insertion tool. For example, a tip may bea rigid plastic tip or “dilator” constructed to attach to an end of anelongate insertion tool by snapping or otherwise securing to the end ofthe tool. The tool can then be used to push or pull the connectorthrough a tissue passage to also bring the extension portion of theimplant through the tissue passage.

Different components of exemplary implants, e.g., support portion,central support portion, extension portions, tensioning members (e.g.,sutures), etc., can be formed separately and assembled by methods suchas those described in pending patent application having U.S. Ser. No.11/115,655, filed on Apr. 26, 2005, entitled “SURGICAL IMPLANTS ANDRELATED METHODS,” the entirety of which is incorporated herein byreference.

FIG. 1 illustrates a specific example of an implant. FIG. 1 showssupport member or “implant” 10 having central support portion 2 and twoextension portions or end strips (“extension portions”), 4 and 6.Central support portion 2 includes posterior lobe 3 extending in onedirection laterally from longitudinally-extending extension portions 4and 6, and anterior lobe 5 extending in the other lateral direction fromlongitudinally-extending extension portions 4 and 6. According to thisembodiment, a surgeon can attach posterior lobe 3 of central portion 2to the posterior rectovaginal facia (septum) (RVF), such as at the areadesignated by outlined area 14 of posterior lobe 3. Anterior lobe 5(e.g., at outlined portion 12) can be attached to the pubovaginalcervical fascia (PVCF). One or more points or sections of centralsupport portion 2, such as lobe extensions 16, can then be attachedbilaterally to the uterosacral ligaments (USL).

FIGS. 2 and 2A also illustrates an implant (FIG. 2A in cross section).As illustrated, implant 20 may be prepared from polymeric (e.g.,polypropylene) mesh strip extension portions 22 and 24 attached (e.g.,sutured) to central support portion 26, which may be synthetic orbiologic. Sutures 28 extend from central support portion 26 along thelengths of each extension portion 22 and 24. Sutures 28 can function astension control members and as repositioning means to effectpositioning, tightening, or loosening, of the extension portions or theimplant.

When implant 20 is installed, anterior lobe 30 can be attached topubovaginal cervical fascia (PVCF) and posterior lobe 32 can be attachedto rectovaginal facia (RVF). Lobe extensions 34 are sufficiently long tobe attached to the sacrum. Alternately, lobe extensions 34 can betrimmed to a length to accommodate attaching each lobe extension to auterosacral ligament (USL). Far ends of each of extension portions 22and 24 can then be attached anatomically to support the posteriorvaginal wall, e.g., using external incisions at the perirectal region toextend extensions 22 and 24 through pathways in tissue at the regions ofthe ischial spine, with each of extensions 22 and 24 extending from eachside of the cervical ring.

FIG. 3 illustrates another example of an implant. FIG. 3 shows implant36 having central support portion 42 and extension portions 38 and 40.As illustrated all of implant 36 is formed from a single piece of meshby cutting to the shape of central support portion 42 and extensionportions 38 and 40. Central support portion 42 includes anterior lobe 44extending in one direction laterally from longitudinally-extendingextension portions 38 and 40, and posterior lobe 46 extending in theother lateral direction from longitudinally-extending extension portions38 and 40. Posterior lobe 46 also includes lobe extensions 48. Wheninstalled, posterior lobe 46 can be attached to the posteriorrectovaginal facia (septum) (RVF) and anterior lobe 44 can be attachedto the pubovaginal cervical fascia (PVCF). Lobe extensions 48 can beattached bilaterally to the uterosacral ligaments (USL), or may beattached to the sacrum.

Another exemplary pelvic implant is at FIG. 4, showing implant 50 thatcan be useful as a pelvic implant. Central support portion 56 can beattached to vaginal tissue and lobe extensions 51 are sufficiently longto be attached to the sacrum or may be trimmed to a length toaccommodate attaching each lobe extension 51 to a uterosacral ligament(USL). Implant 50 includes extension portions 52 and 54 connected tocentral support portion 56. Sutures 60, which are optional and notrequired, extend along the lengths of each of extension 52 and 54. Inthe illustration, polymeric rivets 58 secure extension portions 52 and54 to central support portion 56 and to sutures 60. Optional tips (or“dilators”), or other connection mechanisms, 62 are attached at each ofthe non-attached ends of extension portions 52 and 54. Tips 62 can be,e.g., rigid plastic dilator tips that are shaped to connect to an end ofan implantation device or tool such as a needle. Also shown are optionalsheaths or covers 64, which can be flexible, e.g., transparent coversthat extend over the lengths of each of extensions 52 and 54 from rivet58 to dilator 62, which is crimped over covers 64. Covers 64 can beuseful, e.g., as protection for extensions 52 and 54, and also forinstallation of implant 50, by being sufficiently stiff andnon-elastomeric to allow the extensions to be pulled through a tissuepath by pulling on cover 64.

According to exemplary methods of the invention, a surgeon can attach asupport portion of an implant to the vaginal cuff. A surgeon can attachthe posterior rectovaginal fascia (septum) to the support portion, andthen attach the pubovesicle cervical fascia to another portion of thesupport portion. The support portion (e.g., points or pieces along thebottom of the central support portion) can also be attached or connectedto the sacrum or bilaterally to the uterosacral ligaments. This mayessentially rebuild the cervical ring and support the cervical ring byattachment to the sacrum or uterosacral ligaments. Extension portions ofan implant, attached to the support portion, may be used to furthersupport the vaginal tissue, e.g., by extending bilaterally to supportinganatomy.

Exemplary procedures can be useful in female patients having had ahysterectomy with removal of the cervix. FIG. 5 illustrates an exampleof relevant pelvic anatomy following a hysterectomy, where the cervixhas been removed. As shown, vaginal cuff 70 remains, as do uterosacralligaments 72, which have been detached from the pericervical ring duringthe hysterectomy. Pubocervical fascia 76 is located at the anterior ofvaginal cuff 70, and rectovaginal fascia 74 is located at the posteriorof vaginal cuff 70. Sacrum 85 is also shown.

Referring now to FIG. 6, vaginal cuff 70 is illustrated in dashed lines,beneath central support portion 80. Central support portion 80 includestwo lobe extensions 82. Two extension portions 84, which may be meshstrips, tape, or the like, extend bilaterally from central supportportion 80. Central support portion 80 is attached anteriorly topubocervical fascia 76 and posteriorly to rectovaginal fascia 74, overthe pericervical ring (at the vaginal cuff) opened as a result of theremoval of the cervix with the hysterectomy. Sutures 86 are used toattach tissue to central support portion 80 and extensions 82.Uterosacral ligaments 72, detached from the pericervical ring with thehysterectomy, can be attached to lobe extensions 82 to support centralsupport portion 80 and the pericervical ring and vaginal cuff 70.Accordingly, lobe extensions 82 are of a length to attach to uterosacralligaments 72. Extension portions 84 extend through a tissue passage tobe placed at or approximately at the level of the pericervical ring.

FIG. 7 illustrates the anatomy following installation of an implant,from a side three-dimensional view, relative to vagina 88, buttock 91,and rectum 90. As seen in FIG. 7, extension portions 84 extend fromcentral support portion 80 through tissue paths to external incisions92. In this exemplary embodiment, lobe extensions 82 attach touterosacral ligaments 72.

FIG. 8 illustrates an alternate embodiment of an installed implant ofthe invention. Vaginal cuff 70 is illustrated in dashed lines, beneathcentral support portion 80. Central support portion 80 includes two lobeextensions 82, which are each of a length to reach and attach to sacrum85 with fasteners 87. Extension portions 84, which may be mesh strips,tape, or the like, extend bilaterally from central support portion 80.Central support portion 80 is attached anteriorly to pubocervical fascia76 and posteriorly to rectovaginal fascia 74, over the pericervical ring(at the vaginal cuff). Sutures 86 are used to attach tissue to centralsupport portion 80. Uterosacral ligaments 72 are removed or not shown.Lobe extensions 82 are of sufficient length to attach to sacrum 85, andmay be attached by any useful attachment method and device (87) such asa bone screw, a bone anchor, or adhesive. Extension portions 84 extendthrough a tissue passage to be placed at or approximately at the levelof the pericervical ring.

FIG. 9 illustrates the anatomy following installation of an implant asshown in FIG. 8, from a side three-dimensional view, relative to vagina88, buttock 91, and rectum 90. As seen in FIG. 9, extension portions 84extend from central support portion 80 through tissue paths to externalincisions 92. In this exemplary embodiment, lobe extensions 82 attach tosacrum 85.

The methods described herein can be used generally to support vaginaltissue, especially to prevent enterocele and vaginal vault prolapse. Theimplant can be installed either during a hysterectomy procedure toprophylactically prevent enterocele or prolapse, or the implant can beinstalled later, during a subsequent procedure to a patient who haspreviously undergone a hysterectomy procedure and developed anenterocele with a vaginal prolapse. The hysterectomy may include full orpartial removal of the cervix, or may not remove any tissue of thecervix. The support portion of the implant can be placed on the tissuethat remains, which may be the vaginal cuff or the cervix (these tissuesbeing referred to herein for convenience and brevity as the “vaginalcuff”).

The surgical installation method can involve methods that arelaproscopic, abdominal (involving an abdominal incision) or atransvaginal. In exemplary transvaginal methods, following attachment ofa central support portion of an implant to the vaginal cuff, extensionportions of an implant can be secured to support the central supportportion and the vaginal cuff. This can be done, e.g., by establishingtissue pathways to exterior incisions and leading the extension portionsthrough the tissue pathways.

Exemplary methods of providing tissue pathways from the vaginal regionto external incisions, for installing an implant to support vaginaltissue, are described in U.S. patent application Ser. No. 10/834,943,entitled “Method and Apparatus for Treating Pelvic Organ Prolapse,”filed Apr. 30, 2004. Other methods will also be useful. As described inthe referenced patent application, two tissue pathways are establishedbetween the external perirectal region and the region of the ischialspine. Tools useful for this procedure can be straight or curvedneedles, optionally including a tip with an adapter that cooperates witha tip or dilator at the end of extension portions of the implant, toallow the dilator of the end portion to be attached to the tip of theneedle to lead the dilator and extension portion to a desired location,e.g., through a tissue path to an external incision.

A useful needle can be generally curved or arcuate. A variety of needledesigns may be used including, without limitation, straight, bent,curved, arc-shaped, Stamey, Raz and other configurations. Another toolthat may be useful is a tunneler (e.g., the IVS Tunneler deviceavailable commercially from Tyco), which can also be inserted from anexternal incision to attach to an end of an extension portion to allowthe extension portion to be led from the pelvic region to an externallocation.

An exemplary pathway can be made by making two external incisions in therectal area, and a vaginal incision at the vaginal apex. A needle orother instrument can be passed from the external incision to the vaginalregion, to contact the extension portion of an implant. Followingpassage of the needle or instrument through the tissue pathways, theneedle or instrument tip can be connected to an extension portion of theimplant. Following proper positioning and attachment of the centralsupport portion of the implant to the vaginal cuff, the needle orinstrument can be retracted back through the tissue path and throughexternal incision, carrying the extension portion to the externalincision.

1. A method of supporting vaginal tissue, the method comprisingproviding a surgical implant comprising a support portion, attaching thesupport portion to vaginal or cervical tissue remaining upon removal ofa uterus, cervix, or both, and attaching the support portion to acomponent of sacral anatomy.
 2. The method of claim 1, wherein thesupport portion is attached to a uterosacral ligament.
 3. The method ofclaim 1, wherein the support portion is attached to the sacrum.
 4. Themethod of claim 1 comprising attaching the support portion topubocervical fascia and rectovaginal fascia.
 5. The method of claim 1wherein the implant comprises a central support portion and twoextension portions extending from the central support portion, thecentral support portion comprises: an anterior lobe extending laterallyfrom the extension portions, and a posterior lobe extending laterallyfrom the extension portions in a direction opposite of the anteriorlobe, and the method comprises: attaching the anterior lobe topubocervical fascia, attaching the posterior lobe to rectovaginal fasciaand to a component of sacral anatomy selected from the group consistingof a uterosacral ligament and a sacrum.
 6. The method of claim 5,wherein the posterior lobe comprises two posterior lobe extensions andthe method comprises attaching the posterior lobe extensions to sacralanatomy selected from the group consisting of a uterosacral ligament anda sacrum.
 7. The method of claim 6, wherein the sacral anatomy is asacrum.
 8. The method of claim 6, wherein the sacral anatomy is auterosacral ligament, and the method comprises trimming the lobeextension before attaching the uterosacral ligament to the lobeextension.
 9. The method of claim 5, comprising leading the extensionportions through tissue paths to an exterior incision.
 10. The method ofclaim 1, wherein the method comprises removing the uterus.
 11. Themethod of claim 1, comprising introducing the implant transvaginally.12. The method of claim 1, wherein the method prophylactically preventsa condition selected from vaginal vault prolapse and enterocele.
 13. Themethod of claim 1, comprising providing a surgical implant comprising acentral support portion and two extension portions extending from thecentral support portion, performing a hysterectomy to remove a uterusand leave tissue of a vaginal cuff or cervix, attaching the centralsupport portion to the vaginal cuff or cervix, attaching the centralsupport portion to sacral anatomy selected from the group consisting ofa uterosacral ligament and a sacrum, leading the extension portions ofthe implant through tissue paths to an external incision, and suturingthe vaginal cuff or cervix to close the vaginal vault.
 14. Atransvaginal method of supporting vaginal tissue, the method comprisingproviding a surgical implant, transvaginally attaching the surgicalimplant to vaginal or cervical tissue remaining after removal of auterus, cervix, or both, and transvaginally attaching the supportportion to a component of sacral anatomy.
 15. The method of claim 14,comprising transvaginally performing a hysterectomy, providing asurgical implant comprising a central support portion and two extensionportions extending from the central support portion, attaching thecentral support portion to the vaginal or cervical tissue, attaching thecentral support portion to sacral anatomy selected from the groupconsisting of a uterosacral ligament and a sacrum, leading the extensionportions of the implant through tissue pathways to an external incision,and suturing the vaginal or cervical tissue to close the vaginal vault.16. The method of claim 15, comprising establishing a first pathway intissue on a first side of the vagina, the pathway extending between anexternal perirectal region to a region of an ischial spine of thepatient; establishing a second pathway in tissue on a contra-lateralside of the vagina, the pathway extending between an external perirectalregion to a region of an ischial spine of the patient; using a tunnelerdevice or needle to introduce an extension portion through the first andsecond pathways.
 17. A surgical implant comprising a central supportportion and two extension portions extending longitudinally from thecentral support portion, the central support portion comprising ananterior lobe extending laterally from the extension portions, and aposterior lobe extending laterally from the extension portions in adirection opposite of the anterior component, the posterior lobecomprising two lobe extensions.
 18. The implant of claim 17, sized andshaped to be installed to support vaginal tissue, wherein the centralsupport portion is sized and shaped to be attached to vaginal orcervical tissue after removal of a uterus, a cervix, or both, byattaching the anterior lobe to pubocervical fascia, attaching theposterior lobe to rectovaginal fascia, and attaching the lobe extensionsto anatomy selected from a uterosacral ligament and a sacrum.
 19. A kitcomprising the implant of claim 17, further comprising instructions forinstalling the implant transvaginally.
 20. A kit comprising the implantof claim 17, further comprising a tunneler or needle useful for placingthe extension portions of the implant through tissue paths.